New Food Raw Material Registration in China

In
accordance with Food Safety Law of the People's Republic of China, companies
that plan to use new food raw materials to manufacture food products shall
submit the related safety assessment material of the new food raw material to National
Health Commission of the People's Republic of China (former NHFPC).

New food raw material
in China

New
food raw material refers to the following substances that have no traditional
eating habits in China, including:

Animals,
plants and microorganisms;

Components
extracted from animals, plants and microorganisms;

Food
ingredients that have changed in the original structure;

Other
newly developed food ingredients.

New
food raw materials should have the characteristics of food raw materials and
conform to the requirements of nutritive. It shall be non-toxic, harmless, and
not cause any acute, subacute, chronic or other potential hazards to human
body.

For
imported new food raw material, besides the above documents, the following
supplementary documents also should be submitted:

10)
Certifying documents issued by government authorities or industry associations
in the exporting country (region) of origin, proving that the new food raw
material is allowed to manufacture or sell in the country (region).

11)
Certifying documents issued by government authorities or industry associations
in the producing country (region) of origin, proving that the new food raw
material manufacturer has been examined or certificated.

Test requirements

Composition
analysis report: the test results and methods of main components and possible
harmful components.

Hygienic
inspection report: the test results and methods of pollutants and
microorganism.

Toxicology
safety assessment documents:

Conditions

Test requirements in principle

No traditional eating habit of
domestic and overseas (excluding microorganism)

Acute oral toxicity test;

Three genetic toxicity tests;

90-day oral toxicity test;

Teratogenic and reproductive toxicity
tests;

Chronic toxicity and carcinogenicity tests;

Metabolic test.

Only have traditional eating habit in
several foreign countries or local areas (excluding microorganism)

Acute oral toxicity test;

Three genetic toxicity tests;

90-day oral toxicity test;

Teratogenic and reproductive toxicity
tests.

Widely approved to use in many
countries (excluding microorganism)

Acute oral toxicity test;

Three genetic toxicity tests;

28-day oral toxicity test.

Microorganism that without traditional
eating habit of domestic and overseas

Acute oral toxicity test/Pathogenicity
test;

Three genetic toxicity tests;

90-day oral toxicity test;

Teratogenic and reproductive toxicity
tests.

Microorganism that only have traditional
eating habit in several foreign countries or local areas